Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)

Phase 2a, Double-blind, Placebo-controlled, 2-period, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 in Patients With Inherited Erythromelalgia.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01090622

Enrollment

Registered

2010-03-22

Start date

2010-04-30

Completion date

2010-09-30

Last updated

2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inherited Erythromelalgia, Primary Erythromelalgia

Brief summary

The purpose of this study is to determine whether XPF-001 is safe and effective in the treatment of pain caused by Inherited Erythromelalgia (IEM).

Interventions

DRUGXPF-001

Oral capsule

DRUGPlacebo

Oral capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

The study requires you to: * Be18-75 years old * Have inherited erythromelalgia * Be experiencing pain caused by erythromelalgia (Moderate pain score 4/10) * Be generally healthy (apart from your pain) * Stop taking your usual pain medications for 9 days * Not be pregnant or breast-feeding Your role in the study includes: * An out-patient screening visit * 9-days/8 nights-in-patient treatment visit at Nijmegen Medical Center (where you will be closely monitored) * A follow up phone call (after your return home) * Taking the investigational medication daily * Recording your pain levels daily during stay at the Medical Center.

Exclusion criteria

* Coexistent source of pain from other conditions * Receiving professional psychological support for dealing with IEM * Treatment for significant depression within 6 months of screening * Active HIV, Hepatitis B or C * Use of prescription or OTC medication between check-in and discharge * Women who are pregnant, or lactating * Not currently using adequate contraception * Alcoholism or alcohol or substance abuse * Presence or history of major psychiatric disturbance * Unwilling or unable to comply with all dietary and activity restrictions * Any other condition or finding that may pose undue risk for participation * Use of any other investigational drug in the 60 days prior to dosing

Design outcomes

Primary

Measure	Time frame
Pain intensity difference (PID) in each treatment period based on an 11-point Pain Intensity-NRS (where 0 = No pain and 10 = worst pain you can imagine)	2 days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026